Flat Panel Digital X-ray Detector
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Flat Panel Digital X-ray Detector EUDAMED
- Model / Reference
- EXPD 129P EUDAMEDEXPD 114P EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018408704 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000184DGXXXXXXXXRV EUDAMED
- Direct Marketing DI
- 08800018408704 EUDAMED
- 510(k) Number
- K242770 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary basic diagnostic x-ray system, digital
Flat Panel Digital X-ray Detector by DRTECH Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000184DGXXXXXXXXRV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DRTECH Corporation
- EUDAMED SRN
- KR-MF-000012441
- Authorised Representative
- DRTECH Europe GmbH DE-AR-000011974
Sources (2)
- EUDAMED 11d19a1d-50ea-43d6-8a0a-cc1c30235719 61 fields · synced Jun 6, 2026
- FDA UDI 7261ab6f-510a-456b-a68d-105560617ec7 33 fields · synced May 29, 2026